Introduction to FDAIntroduction to FDA

�� Frank EngFrank Eng

�� IEEEIEEE--LEOSLEOS

�� February 2006February 2006

U.S. Dept. of Health & Human U.S. Dept. of Health & Human

Services Services –– 12+ ‘Bureaucracies’12+ ‘Bureaucracies’�� Administration for Children and Families (ACF)Administration for Children and Families (ACF)

�� Administration on Aging (Administration on Aging (AoAAoA))

�� Agency for Healthcare Research and Quality (AHRQ)Agency for Healthcare Research and Quality (AHRQ)

�� Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Toxic Substances and Disease Registry (ATSDR)

�� Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC)(CDC)

�� Centers for Medicare & Medicaid Services Centers for Medicare & Medicaid Services (CMS)(CMS)

�� Food and Drug Administration (FDA)Food and Drug Administration (FDA)�� Health Resources and Services Administration (HRSA)Health Resources and Services Administration (HRSA)

�� Indian Health Service (IHS)Indian Health Service (IHS)

�� National Institutes of Health (NIH)National Institutes of Health (NIH)�� Program Support Center (PSC)Program Support Center (PSC)

�� Substance Abuse and Mental Health Services Substance Abuse and Mental Health Services Administration (SAMHSA)Administration (SAMHSA)

CDC's Mission: To promote health and quality of life by preventing and

controlling disease, injury, and disability.

National Center on Birth Defects and Developmental DisabilitiesNational Center for Chronic Disease Prevention and Health Promotion

National Center for Environmental Health

National Center for Health Statistics.

National Center for HIV, STD, and TB PreventionNational Center for Infectious Diseases

National Center for Injury Prevention and Control

National Immunization ProgramNational Institute for Occupational Safety and Health

Epidemiology Program Office

Public Health Practice Program Office

National Cancer InstituteNational Cancer Institute

National Eye InstituteNational Eye Institute

National Heart, Lung, and Blood InstituteNational Heart, Lung, and Blood Institute

National Human Genome Research InstituteNational Human Genome Research Institute

National Institute on AgingNational Institute on Aging

National Institute on Alcohol National Institute on Alcohol Abuse&AlcoholismAbuse&Alcoholism

National Institute of Allergy&Infectious National Institute of Allergy&Infectious DiseasesDiseases

National Institute of Arthritis & National Institute of Arthritis & Musculoskeletal and Skin DiseasesMusculoskeletal and Skin Diseases

National Institute of Biomedical Imaging and National Institute of Biomedical Imaging and BioengineeringBioengineering

National Institute of Child Health & Human National Institute of Child Health & Human DevelopmentDevelopment

National Institute on Deafness and Other National Institute on Deafness and Other Communication DisordersCommunication Disorders

National Institute of Dental & Craniofacial National Institute of Dental & Craniofacial ResearchResearch

National Institute of Diabetes and Digestive National Institute of Diabetes and Digestive and Kidney Diseasesand Kidney Diseases

National Institute on Drug AbuseNational Institute on Drug Abuse

National Institute of Environmental Health National Institute of Environmental Health SciencesSciences

Mission: Steward of medical and behavioral research for the Nation

National Institute of General Medical Sciences National Institute of Mental Health

National Institute of Neurological Disorders & Stroke Library of Medicine

Center for Information TechnologyCenter for Scientific Review John E. Fogarty International CenterNational Center for Complementary and Alternative MedicineNational Center on Minority Health and Health Disparities National Center for Research Resources NIH Clinical Center

FDA is a Regulatory AgencyFDA is a Regulatory Agency

�� FDA regulates products, not practices!FDA regulates products, not practices!

�� Food, Drug & Cosmetic ActFood, Drug & Cosmetic Act

�� Also the RCHSA and the BT Act, etcAlso the RCHSA and the BT Act, etc

�� RegsRegs: Title 21CFR, parts 1 to 1299: Title 21CFR, parts 1 to 1299

�� 9,000 Employees (about 1,000 are in 9,000 Employees (about 1,000 are in

ORA field offices around the country)ORA field offices around the country)

FDA Organizational Units are:FDA Organizational Units are:

�� CFSAN CFSAN -- Foods & Cosmetics, CFR 100Foods & Cosmetics, CFR 100

�� CDER CDER –– Drugs, CFR 200Drugs, CFR 200

�� CVM CVM -- Vet Med & Vet Devices, CFR 500Vet Med & Vet Devices, CFR 500

�� CBER CBER -- Blood & Biologics, CFR 600Blood & Biologics, CFR 600

�� CDRH CDRH -- Devices & Devices & RadRad Health, CFR 800Health, CFR 800

�� ORA ORA –– Inspectional Arm of FDAInspectional Arm of FDA

PrePre--ApprovalsApprovals

�� Not Required for:Not Required for:

Food & Cosmetic products Food & Cosmetic products

(exceptions: food & color additives)(exceptions: food & color additives)

�� Required for:Required for:

Drugs, Devices, Blood, Biologics, & Drugs, Devices, Blood, Biologics, &

Vet Med products Vet Med products

… but with exceptions as indicated in … but with exceptions as indicated in

the CFR (i.e.: tongue depressors)the CFR (i.e.: tongue depressors)

Center for Food Center for Food

Safety & Applied Safety & Applied

NutritionNutrition

�� Food safetyFood safety

•• BT ActBT Act

•• Seafood HACCPSeafood HACCP

•• Pesticide residuesPesticide residues

•• ImportsImports

�� Approval and safety Approval and safety

of food additives of food additives

�� Cosmetic safetyCosmetic safety

�� Labeling Labeling –– foods, foods,

cosmetics and cosmetics and

dietary supplementsdietary supplements

What CFSAN does What CFSAN does NOTNOT regulateregulate

�� Restaurants & Grocery Stores (local Restaurants & Grocery Stores (local HDsHDs))

�� Meat, Poultry, Eggs (USDA) Meat, Poultry, Eggs (USDA) (FDA is responsible for game meats and products (FDA is responsible for game meats and products

containing <3% raw meat or <2% cooked meat)containing <3% raw meat or <2% cooked meat)

�� Advertising for dietary supplements, Advertising for dietary supplements,

food, cosmetics (FTC)food, cosmetics (FTC)

�� Alcohol (TTB,Alcohol (TTB, Alcohol & Tobacco Tax & Trade BureauAlcohol & Tobacco Tax & Trade Bureau))

�� Water (EPA) Water (EPA) (FDA is responsible for bottled water)(FDA is responsible for bottled water)

••RX, Generic, OTC Drugs:

- NDAs and ANDAs

• Drug Clinical Investigations:- INDs

• Good Manufacturing Practices• Adverse event reporting • RX Drug Advertising

Center for Drug

Evaluation and Research

What CDER does What CDER does NOTNOT regulateregulate

�� Illicit drugs (DEA)Illicit drugs (DEA)

�� Triplicates (DEA)Triplicates (DEA)

�� OTC drug advertising (FTC)OTC drug advertising (FTC)

�� Methadone treatment (SAMHSA)Methadone treatment (SAMHSA)

Center for Veterinary Medicine

What CVM does What CVM does NOTNOT regulate:regulate:

�� Animal Vaccines (USDA)Animal Vaccines (USDA)

�� Meat products (USDA)Meat products (USDA)

CBER

Center for Biologics

• Blood supply• Vaccines for human use• Human tissue • Allergenic materials and anti-toxins

What CBER does What CBER does NOTNOT regulateregulate

�� Organs (HRSA)Organs (HRSA)

�� Drugs (CDER)Drugs (CDER)

Center for Devices & Radiological Health

CDRH CDRH –– Medical DevicesMedical Devices

�� Market via: Market via: PMAsPMAs or 510(k)sor 510(k)s

�� Clinical Investigations, Clinical Investigations, IDEsIDEs required required

for significant risk devicesfor significant risk devices

�� Quality System Regulations (Quality System Regulations (GMPsGMPs), ),

21CFR 82021CFR 820

�� Adverse Event Reporting SystemAdverse Event Reporting System--

MDR/MDR/MedwatchMedwatch ReportsReports

RadHealthRadHealth part of CDRHpart of CDRH

�� Electronic Radiation Emitting Electronic Radiation Emitting

Products Products (Medical & Non(Medical & Non--Medical),Medical),

21CFR 1000 21CFR 1000

�� NonNon--Medical Products such as: Medical Products such as:

TVs (CRT version), microwave TVs (CRT version), microwave

ovens, tanning beds, laser ovens, tanning beds, laser

products, mammography & xproducts, mammography & x--ray ray

products.products.

What CDRH does What CDRH does NOTNOT regulateregulate

�� Plastic gloves (CPSC)Plastic gloves (CPSC)

�� Toaster ovens (CPSC)Toaster ovens (CPSC)

�� Advertising for tanning booths (FTC)Advertising for tanning booths (FTC)

�� Nuclear materials in hospitals (NRC)Nuclear materials in hospitals (NRC)

FDA’s FDA’s RadRad Health WebsiteHealth Website

�� www.www.fdafda..govgov/CDRH/comp_/CDRH/comp_

nonionnonion_products.html_products.html

FDA Inspections FDA Inspections -- ORAORA

Drug & Device InspectionsDrug & Device Inspections

�� RoutineRoutine

�� PrePre--ApprovalApproval

�� PostPost--ApprovalApproval

�� For CauseFor Cause

Medical Device InspectionsMedical Device Inspections

�� Quality System Requirements, Quality System Requirements,

21CFR 82021CFR 820 (similar to ISO 9001)(similar to ISO 9001)

�� Management ControlsManagement Controls

�� Design ControlsDesign Controls

�� CAPACAPA-- corrective & preventive corrective & preventive

actionsactions

�� Production & Process ControlsProduction & Process Controls

Medical Fields #1Medical Fields #1

�� Clinical ChemistryClinical Chemistry

�� Hematology/PathologyHematology/Pathology

�� Immunology/MicrobiologyImmunology/Microbiology

�� AnesthesiologyAnesthesiology

�� CardiovascularCardiovascular

�� DentalDental

�� Ear, Nose & ThroatEar, Nose & Throat

Medical Fields #2Medical Fields #2

�� GastroenterologyGastroenterology--UrologyUrology

�� General & Plastic SurgeryGeneral & Plastic Surgery

�� General HospitalGeneral Hospital

�� NeurologicalNeurological

�� OphthalmicOphthalmic

�� Orthopedic/Physical MedicineOrthopedic/Physical Medicine

�� RadiologyRadiology

�� etcetc

Technologies EncounteredTechnologies Encountered

�� Electronics, Software & Electronics, Software &

HardwareHardware

�� Rubber, Plastics & MetalRubber, Plastics & Metal

�� Purification: air, water, etc.Purification: air, water, etc.

�� BioBio--Engineering: Engineering:

mono/polyclonal antibodies, etc.mono/polyclonal antibodies, etc.

�� Sterilization: gas, steam, heat & Sterilization: gas, steam, heat &

radiation, plasmaradiation, plasma

Medical Device InspectionsMedical Device Inspections

Primary Problem AreasPrimary Problem Areas

�� Management ControlsManagement Controls

�� Design ControlDesign Control

�� Validation IssuesValidation Issues

�� Corrective & Preventative Corrective & Preventative

ActionsActions

Laser InspectionsLaser Inspections

�� Purpose: Purpose:

To determine a manufacturer’s To determine a manufacturer’s

conformance with the Laser conformance with the Laser

Product Performance Standard Product Performance Standard

(safety features and labeling (safety features and labeling

requirements)requirements)

Laser InspectionsLaser Inspections

Items CoveredItems Covered

�� Organization ChartOrganization Chart

�� Product & Annual ReportsProduct & Annual Reports

�� Marketing BrochuresMarketing Brochures

�� User’s Manuals, and or Service User’s Manuals, and or Service

ManualsManuals

�� Quality Control ProceduresQuality Control Procedures

�� Manufacturing RecordsManufacturing Records

�� Equipment Calibration RecordsEquipment Calibration Records

Laser Inspections Laser Inspections

Primary Problem AreasPrimary Problem Areas

�� Lack of documentation to show Lack of documentation to show

conformance with the LPPSconformance with the LPPS

�� Lack of Product/Annual ReportsLack of Product/Annual Reports

�� Inadequate labeling.Inadequate labeling.

�� Lack of required safety features.Lack of required safety features.

�� Failure to report corrective Failure to report corrective

actions.actions.

Laser InspectionsLaser Inspections

Primary Advice GivenPrimary Advice Given

�� Laser Notice 50Laser Notice 50

Within certain requirements, Within certain requirements, manufacturers are allowed to use manufacturers are allowed to use yellow & black *European style yellow & black *European style labels, in lieu of the traditional labels, in lieu of the traditional red/black/white American style red/black/white American style labels.labels.

* IEC 60825* IEC 60825--1 & IEC 606011 & IEC 60601--22--2222

Regional Small Business RepresentativeRegional Small Business Representative

�� Helps small businesses whose products Helps small businesses whose products

are regulated by FDAare regulated by FDA

�� Provides information that clarifies how Provides information that clarifies how

agency laws and regulations apply to their agency laws and regulations apply to their

businessbusiness

�� Suggest methods to meet requirementsSuggest methods to meet requirements

�� Respond to inquiries, conduct or Respond to inquiries, conduct or

participate in workshops and conferences, participate in workshops and conferences,

or visit your plant, at your request, to or visit your plant, at your request, to

offer assistanceoffer assistance

Marsha Madrigal (510) 637-3980

Consumer ComplaintsConsumer Complaints

�� Charla Tate @ (510) 337Charla Tate @ (510) 337-- 67416741

•• FoodsFoods

•• DrugsDrugs

•• Devices Devices

•• BloodBlood

•• CVMCVM

What complaints are What complaints are notnot FDA’sFDA’s

�� Problem with restaurant food (HD)Problem with restaurant food (HD)

�� Problem with physician (MB)Problem with physician (MB)

�� Problem with pharmacy (Problem with pharmacy (BoPBoP))

What about the State?What about the State?

�� DHS DHS -- Food and Drug Branch (916) 650Food and Drug Branch (916) 650--6500 6500

http://www.dhs.ca.gov/fdb/http://www.dhs.ca.gov/fdb/

�� Food and Agriculture (800) 675Food and Agriculture (800) 675--2427 2427

http://www.cdfa.ca.gov/http://www.cdfa.ca.gov/

�� Department of Consumer Affairs (800) 952Department of Consumer Affairs (800) 952--5210 5210

http://www.dca.ca.gov/http://www.dca.ca.gov/

�� Board of Pharmacy (916) 445Board of Pharmacy (916) 445--5014 5014

http://www.pharmacy.ca.gov/http://www.pharmacy.ca.gov/

�� Medical Board (800) 633Medical Board (800) 633--2322 2322

http://www.medbd.ca.gov/http://www.medbd.ca.gov/

�� Others: Cal EPA, EHIBOthers: Cal EPA, EHIB

�� Food Stamp, School Lunch, School Breakfast, and the WIC Food Stamp, School Lunch, School Breakfast, and the WIC ProgramsPrograms

�� Oversees 192 million acres of national forests and Oversees 192 million acres of national forests and rangelandsrangelands

�� Conservation to protect soil, water, wildlife on the 70 % Conservation to protect soil, water, wildlife on the 70 % private lands private lands

�� Housing, telecommunications, and safe drinking water to Housing, telecommunications, and safe drinking water to rural Americarural America

�� USDA is responsible for the safety of meat, poultry, and egg USDA is responsible for the safety of meat, poultry, and egg products products

�� USDA is a research leader in everything from human USDA is a research leader in everything from human nutrition to new crop technologiesnutrition to new crop technologies

�� USDA helps ensure open markets for U.S. agricultural USDA helps ensure open markets for U.S. agricultural products and provides food aid to needy people overseas. products and provides food aid to needy people overseas.

USDA AgenciesUSDA AgenciesAgricultural Research Service Agricultural Research Service

Animal and Plant Health Animal and Plant Health Inspection ServiceInspection Service

Center for Nutrition Policy Center for Nutrition Policy and Promotion and Promotion

Cooperative State Research, Cooperative State Research, Education and Extension Education and Extension ServiceService

Economic Research ServiceEconomic Research Service

Farm Service Agency Farm Service Agency

Food and Nutrition ServiceFood and Nutrition Service

Food Safety & Inspection Food Safety & Inspection ServiceService

Foreign Agricultural Foreign Agricultural Service Service

Forest Service Forest Service

Grain Inspection, Packers Grain Inspection, Packers and Stockyards and Stockyards Administration Administration

National Agricultural National Agricultural Library Library

National Agricultural National Agricultural Statistics Service Statistics Service

Natural Resources Natural Resources Conservation Service Conservation Service

Risk Management Agency Risk Management Agency

Rural DevelopmentRural Development

�� ImportsImports

•• DutiesDuties

•• International agreementsInternational agreements

•• BTBT

•• Commercial enforcementCommercial enforcement

•• Regulatory auditsRegulatory audits

•• Commercial enforcementCommercial enforcement

•• CarriersCarriers

Vigilance, Service, Integrity

Department of CommerceDepartment of Commerce

�� BUREAU OF CONSUMER PROTECTIONBUREAU OF CONSUMER PROTECTION•• Division of Advertising PracticesDivision of Advertising Practices

•• Division of EnforcementDivision of Enforcement

•• Division of Financial PracticesDivision of Financial Practices

•• Division of Marketing PracticesDivision of Marketing Practices

•• Division of Planning and InformationDivision of Planning and Information

•• Consumer and Business Education Consumer and Business Education ProgramProgram

•• International Division of Consumer International Division of Consumer ProtectionProtection

�� BUREAU OF COMPETITIONBUREAU OF COMPETITION•• Mergers and AntiMergers and Anti--trust lawstrust laws

�� BUREAU OF ECONOMICSBUREAU OF ECONOMICS

Department of JusticeDepartment of Justice

�� Investigation/prosecution of controlled substance laws Investigation/prosecution of controlled substance laws

�� Investigation/prosecution of criminals and drug gangs who Investigation/prosecution of criminals and drug gangs who perpetrate violence in our communities and terrorize citizens perpetrate violence in our communities and terrorize citizens through fear and intimidation. through fear and intimidation.

�� National drug intelligence program with federal, state, local, aNational drug intelligence program with federal, state, local, and nd foreign officials on drug intelligence information. foreign officials on drug intelligence information.

�� Seizure and forfeiture of assets derived from illicit drug traffSeizure and forfeiture of assets derived from illicit drug trafficking. icking.

�� Enforcement of the provisions of the Controlled Substances Act aEnforcement of the provisions of the Controlled Substances Act as s they pertain to the manufacture, distribution, and dispensing ofthey pertain to the manufacture, distribution, and dispensing oflegally produced controlled substances. legally produced controlled substances.

�� Coordination/cooperation with federal, state and local law Coordination/cooperation with federal, state and local law enforcement on mutual drug enforcement efforts and reduction of enforcement on mutual drug enforcement efforts and reduction of abuseabuse--type drugs on market through type drugs on market through nonenforcementnonenforcement methods i.e. methods i.e. crop eradication or substitutioncrop eradication or substitution

�� Liaison with the United Nations, Interpol, and other organizatioLiaison with the United Nations, Interpol, and other organizations ns on matters relating to international drug control programs. on matters relating to international drug control programs.

Federal agency? Federal agency?

Federal Information Center Federal Information Center

(800) 688(800) 688--98899889